Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV
• Intervention / Treatment: Drug: E/C/F/TAF; Drug: E/C/F/TDF Placebo; Drug: E/C/F/TDF; Drug: E/C/F/TAF Placebo

• Study Type: Interventional
• Enrollment (Actual): 872
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H2L 4P9
    • Clinique médicale l'Actuel
  • Toronto, Canada, M5G 1K2
    • Maple Leaf Research
  • Toronto, Canada, M4N 3M5
    • University Health Network/Toronto General Hospital
  • Vancouver, Canada, V6Z 2T1
    • Spectrum Health Care
  • Quebec
    • Montreal, Quebec, Canada, H2X 2P4
      • Research Institute of McGill University Health Care
• Dominican Republic
  • Santo Domingo, Dominican Republic, 99999
    • Instituto Dominicano de Estudios Virologicos--IDEV
• France
  • Lyon, France, 69004
    • Hopital de la Croix Rousse
  • Montpellier, France, 34295
    • University Hospital of Montpellier (CHU-Gui de Chauliac)
  • Nice, France, 06200
    • Archet 1 CHU de Nice, Department of Infectiology
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Paris, France, 75010
    • Saint Louis Hospital of Infectious Diseases
  • Tourcoing, France, 59208
    • Ch Tourcoing
• Italy
  • Bologna, Italy, 40138
    • Universitaria di Bologna-Policlicnico S' Orsola Malpighi
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
• Mexico
  • Guadalajara, Mexico, 44280
    • Hospital Civil de Guadalajara
  • Mexico City, Mexico, 14080
    • Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
• Portugal
  • Coimbra, Portugal, 3000-075
    • Serviço de Doenças Infecciosas, HUC-CHUC, EPE
  • Lisboa, Portugal, 1169-050
    • Hospital Santo Antonio dos Capuchos
  • Lisbon, Portugal, 1649-035
    • Hospital de Santa Maria - CHLN, EPE
  • Porto, Portugal, 4369-004
    • Centro Hospitalar do Porto - Hospital Joaquim Urbano
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Hope Clinical Research
  • San Juan, Puerto Rico, 00935
    • University of Puerto Rico ACTU
• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital, Huddinge
  • Stockholm, Sweden, 11883
    • Venhalsan / Sodersjukhuset
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Heart of England NHS Foundation Trust
  • Birmingham, United Kingdom, B4 6DH
    • Whittall Street Clinic
  • Brighton, United Kingdom, BN2 1ES
    • Brighton and Sussex University Hospitals NHS Trust
  • Glasgow, United Kingdom, G12 0YN
    • Brownlee Centre, Gartnavel General Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, SE5 9RJ
    • Kings College Hospital
  • London, United Kingdom, WC1E 6JB
    • Mortimer Market Centre
  • London, United Kingdom, E11BB
    • Barts Health NHS Trust
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Spectrum Medical Group
  • California
    • Los Angeles, California, United States, 90069
      • Anthony Mills MD Inc
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente - Los Angeles Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California AIDS Clinical Trials Group
    • Los Angeles, California, United States, 90036
      • Peter J. Ruane, Inc.
    • Oakland, California, United States, 94602
      • Alameda County Medical Center
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Medical Group
    • San Diego, California, United States, 92103
      • La Playa Medical Group and Clinical Research
    • San Francisco, California, United States, 94118
      • Kaiser Permanente San Francisco
    • San Leandro, California, United States, 94577
      • Kaiser Permanente
    • Torrance, California, United States, 90275
      • Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Denver, Colorado, United States, 80209
      • Apex Research LLC
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Dupont Circle Physicians Group
    • Washington, District of Columbia, United States, 20036
      • Capital Medical Associates, PC
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates
    • Washington, District of Columbia, United States, 20009
      • Whitman-Walker Health
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Gary J. Richmond,M.D.,P.A.
    • Fort Pierce, Florida, United States, 34952
      • Midway Immunology and Research Center
    • Miami, Florida, United States, 33133
      • AIDS Healthcare Foundation
    • Miami Beach, Florida, United States, 33139
      • AIDS Healthcare Foundation
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Orlando, Florida, United States, 32836
      • Idocf/Valuhealthmd
    • Sarasota, Florida, United States, 32504
      • Infectious Diseases Associates of NW FL
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute Inc.
    • Tampa, Florida, United States, 33614
      • St. Joseph's Comprehensive Research Institute
    • Tampa, Florida, United States, 33602
      • University of South Florida
    • West Palm Beach, Florida, United States, 33401
      • Triple O Research Institute PA
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
    • Atlanta, Georgia, United States, 30309
      • Atlanta ID Group, PC
    • Atlanta, Georgia, United States, 30309
      • Emory University
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialist of Atlanta
    • Macon, Georgia, United States, 31201
      • Mercer University
  • Hawaii
    • Honolulu, Hawaii, United States, 96821
      • University of Hawaii - Hawaii Center for AIDS
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The Ruth M. Rothstein CORE Center
    • Chicago, Illinois, United States, 60305
      • Rush University Medical Center, Section of Infectious Diseases
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Community Research Initiative of New England
    • West Springfield, Massachusetts, United States, 01105
      • The Research Institute
  • Michigan
    • Berkley, Michigan, United States, 48072-3436
      • Be Well Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63139
      • Southampton Healthcare, Inc.
    • Saint Louis, Missouri, United States, 63108
      • Central West Clinical Research
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Southwest CARE Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Albany, New York, United States, 12208
      • Upstate ID Assoc
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital - Division of Infectious Diseases
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10011
      • Chelsea Village Medical
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina AIDS Clinical Trials Unit
    • Charlotte, North Carolina, United States, 28207
      • Carolinas Medical Center Myer's Park Clinic
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • East Carolina University The Brody School of Medicine
    • Huntersville, North Carolina, United States, 28078
      • Rosedale Infectious Disseases
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bellaire, Texas, United States, 77401
      • St. Hope Foundation, Inc.
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants
    • Dallas, Texas, United States, 75219
      • Southwest Infectious Disease Clinical Research, Inc.
    • Dallas, Texas, United States, 75215
      • Trinity Health & Wellness Center / AIDS Arms, Inc.
    • Fort Worth, Texas, United States, 76104
      • Tarrant County Infectious Disease Associates
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts, PA
    • Houston, Texas, United States, 77098
      • Gordon E. Crofoot, MD, PA
    • Houston, Texas, United States, 77098
      • Research Access Network
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)
  • Washington
    • Seattle, Washington, United States, 98104
      • Peter Shalit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
• Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
• No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis (PEP) up to 6 months prior to screening
• Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF
• Normal electrocardiogram (ECG)
• Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
• Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function
• Serum amylase ≤ 5 × ULN
• Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
• Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
• Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
• Age ≥ 18 years

Key Exclusion Criteria:

• A new AIDS-defining condition diagnosed within the 30 days prior to screening
• Hepatitis B surface antigen (HBsAg) positive
• Hepatitis C antibody positive
• Individuals experiencing decompensated cirrhosis
• Females who are breastfeeding
• Positive serum pregnancy test
• Have an implanted defibrillator or pacemaker
• Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
• History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
• Participation in any other clinical trial (including observational trials) without prior approval
• Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E/C/F/TAF (Double-Blind); E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily; Other Names: Genvoya®; Drug: E/C/F/TDF Placebo; Tablet administered orally once daily
Active Comparator: E/C/F/TDF (Double-Blind); E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.	Drug: E/C/F/TDF; 150/150/200/300 mg FDC tablet administered orally once daily; Other Names: Stribild®; Drug: E/C/F/TAF Placebo; Tablet administered orally once daily
Experimental: Open-Label E/C/F/TAF; After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily; Other Names: Genvoya®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in CD4+ Cell Count at Week 48		Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96		Baseline; Week 96
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48	Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.	Baseline; Week 48
Percent Change From Baseline in Hip BMD at Week 96	Hip BMD was assessed by DXA scan.	Baseline; Week 96
Percent Change From Baseline in Spine BMD at Week 48	Spine BMD was assessed by DXA scan.	Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 96	Spine BMD was assessed by DXA scan.	Baseline; Week 96
Change From Baseline in Serum Creatinine at Week 48		Baseline; Week 48
Change From Baseline in Serum Creatinine at Week 96		Baseline; Week 96
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48	Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.	Baseline; Week 48
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96	Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.	Baseline; Week 96
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48	Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.	Baseline; Week 48
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96	Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.	Baseline; Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Weeks 48 and 96
Percentage of Participants With Treatment-emergent Proteinuria Through Week 48	Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.	Baseline to Week 48
Percentage of Participants With Treatment-emergent Proteinuria Through Week 96	Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.	Baseline to Week 96

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. Erratum In: Lancet. 2016 Apr 30;387(10030):1816.
• Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.
• Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.
• Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.
• Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.
• Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.
• Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.
• Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2013
• Primary Completion (Actual): September 19, 2014
• Study Completion (Actual): October 3, 2018

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: HIV; Women; Female; Treatment Naive; HIV 1 Infected
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GS-US-292-0111; 2013-000102-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No